Impact of a Single Versus Multiple Visits on the Cervical Cancer Screening Completeness, Feasibility and Acceptability Among Women Living With HIV in Cameroon

NCT ID: NCT07177170

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1422 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-12
• Study Completion Date: 2027-05-31

Brief Summary

Context. Cervical cancer (CC) is a leading cause of death among women living with HIV (WLHIV) in resource-limited settings. Yet, effective methods for screening and preventing CC are available. The recommanded approach for CC screening is based on multiple steps, including initial test to detect human papillomavirus (HPV) infection, visual inspection to identify women with HPV at risk for precancerous lesion and treatment when required.

Dropout may occur at these different steps, compromising the success of the CC elimination strategy. Performing the all screening and treatment sequence in a single visit has been recommanded based on the results of a large South African trial. Yet, in many contexts, including those with limited resources, the screening and treatment activities are performed in multiple visites for logistical reasons, resulting in many dropouts. Strategies based on the differentiated prestation approaches, which propose a simplified management centered on the patients preferences, could guide the adaptation of the single-visit approach to account for contextual constraints while maintaining high effectiveness.

The OptiTri-GC study aims to design and assess the impact of a differentiated CC screen and treat strategy in a district hospital; It will assess both its implementation and its effectiveness based on the completeness at each stage of the screening cascade. In addition, it will also include three sub-studies designed to evaluate :

• The performance of urinary HPV testing.
• The performance of different methods to identify women requiring a treatment.
• The risk of post-treatment cervical disease.

This study has two periods. During the first period, a single visit approach will be used while differentiated approach will be prepared using participatory research. During the second period, the differentiated approach will be implemented. The screening overall completeness will be compared between the two periods to assess the differentiated approach effectiveness.

The study will also assess the implementation of each screening strategy in terms of :

• Success through the measure of fidelity, reach and completeness
• Identification of adaptation, barriers and facilitating/leverage factors
• Perception, feasibility and acceptability of the screening strategies (by patients and health care workers) It will assess the participants' stress levels during the screening process and to identify potential psychosocial support strategies and document the experience of WLHIV and health workers during the screening process and the post-treatment follow-up.

Other study objectives include :

• To assess the performance of different methods to identify women requiring a treatment
• To assess the performance of HPV testing on a urine sample compared with vaginal self-collected or cervical (clinician-collected) samples
• To assess the efficacy of treatment in terms of post-treatment cervical lesions

Methodology. Participants will be WLHIV aged 25 to 49 and eligible for CC screening. Health care workers will also be invited to participate to the implementation research. The data collected will be quantitative and qualitative.

Detailed Description

Context. Cervical cancer (CC) is a leading cause of death among women living with HIV (WLHIV) in resource-limited settings. There is compelling evidence that screening for human papillomavirus (HPV) infection by testing is a very sensitive method for identifying women at risk for precancerous lesions of the cervix. But since HPV infections are very common among WLHIV, it is necessary to have secondary triage to identify women who need to be treated.

The HPV-based screening approach includes multiple steps, and dropout may occur at these different steps, compromising the success of the CC elimination strategy. A single-visit screen and treat approach has been recommanded based on the results of a large South African trial. Yet, in many contexts, including those with limited resources, the screening and treatment activities are often performed in multiple visites for logistical reasons, resulting in many dropouts. Strategies based on the differentiated prestation approach, which propose a simplified management centered on the patients preferences, could guide the adaptation of the single-visit approach to account for contextual constraints while maintaining high effectiveness.

The OptiTri-GC study aims to design and assess the impact of a differentiated CC screen and treat strategy in a district hospital; It will assess both its implementation and its effectiveness based on the completeness at each stage of the screening cascade. In addition, it will also include three sub-studies designed to evaluate :

• the performance of urinary HPV testing.
• the performance of different post-HPV test triage options (partial genotyping, simple or Artifical Intelligence assisted visual inspection, methylation markers)
• the risk of post-treatment cervical disease and the performance of different cure markers.

This will be a type 2 hybrid study that combines intervention research and implementation research. A quasi-experimental design ("before - after") combined with case study will be used for the effectiveness component of the research. During the first period, a single visit approach will be used while differentiated approach will be prepared using participatory research. During the second period, the differentiated approach will be implemented.

The general objective of this research is to assess the (cost-)effectiveness and implementation of different the two screening delivery strategies.

Main specific objectives include:

• To assess the effectiveness of each implementation strategy (in terms of cascade completeness)
• To assess the implementation of each strategy in terms of :

• Success through the measure of fidelity, reach and completeness
• Identification of adaptation, barriers and facilitating/leverage factors
• Perception, feasibility and acceptability of the screening strategies (by patients and health care workers)
• To assess the participants' stress levels during the screening process and to identify potential psychosocial support strategies
• To document the experience of WLHIV and health workers during the screening process and the post-treatment follow-up.
• To assess the performance of different triage methods among HPV+ participants (partial genotyping, simple or aided visual inspection, S5 methylation)
• To assess the performance of HPV testing on a urine sample compared with vaginal self-collected or cervical (clinician-collected) samples
• To assess the efficacy of thermal ablation treatment in terms of post-treatment cervical lesions

Methodology. The implementation research will combine quantitative and qualitative methods and will be based on the i-PARHIS model. Participants will be WLHIV aged 25 to 49 and eligible for CC screening. Health care workers will also be invited to participate to the implementation research. The data collected will be quantitative and qualitative. Biomedical data will be collected prospectively. The implementation data will combine routine monitoring data, cross-sectional surveys, interviews and observations. The analysis will be sequential or convergent depending on the stages of the project.

Conditions

Cervical Cancer Screening; HIV

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Single visit

All women will be screened using a single-visit approach

Group Type: ACTIVE_COMPARATOR

Single visit

Intervention Type: OTHER

All the steps of the screening (using HPV test) and of the treatment will be performed in a single visit (when possible).

Differentiated prestation

A more flexible screening approach will be offered based on the participants preference. After counseling (following the decision aid approach), participants may decide to performed the screening in two visits.

Group Type: EXPERIMENTAL

Differentiated screening delivery

Intervention Type: OTHER

More flexibility in the screening delivery will be offered. A decision aid process will be implemented to help the participants deciding between the two options.

Interventions

Differentiated screening delivery

More flexibility in the screening delivery will be offered. A decision aid process will be implemented to help the participants deciding between the two options.

Intervention Type: OTHER

Single visit

All the steps of the screening (using HPV test) and of the treatment will be performed in a single visit (when possible).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• HIV infection
• receiving antiretroviral therapy
• living in the department of the study hospital

Exclusion Criteria

• ongoing pregnancy
• hysterectomy
• treatment of cervical lesion in the past 12 months
• Expected follow-up difficulties: planned absence that could interfere with the participation in the study (e.g., travel abroad, relocation, imminent transfer, etc.);
• Any pathology or concomitant treatment which, in the opinion of the investigators, contraindicates participation or prevents satisfactory participation in the study Inclusion deferred if
• menstrual bleeding
• post-partum (<12 weeks after delivery)
• clinicla signs of cervical or pelvic infection

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ecole Polytechnique Fédérale de Lausanne

OTHER

Sponsor Role: collaborator

Centre Pasteur du Cameroun

OTHER

Sponsor Role: collaborator

Centre Hospitalier Simone Veil

UNKNOWN

Sponsor Role: collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

Queen Mary University of London

OTHER

Sponsor Role: collaborator

Hôpitaux Universitaire de Genève

UNKNOWN

Sponsor Role: collaborator

International Agency for Research on Cancer

OTHER

Sponsor Role: collaborator

Programme PACCI, Abidjan, Côte d'Ivoire

UNKNOWN

Sponsor Role: collaborator

RSD Institute, Cameroon

UNKNOWN

Sponsor Role: collaborator

Institut de Recherche pour le Developpement

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre Debeaudrap, MD, PhD

Role: STUDY_DIRECTOR

Institut de Recherche pour le Développement (IRD)

Joëlle Sobngwi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

RSD Institute

Locations

Foumban hospital

Foumban, , Cameroon

Site Status: RECRUITING

Countries

Cameroon

Central Contacts

Andre-Pascal Goura, MD

Role: CONTACT

cdpoptitri@gmail.com

+227679336464

Facility Contacts

Amadou NJIFOU NJIMAH, Prof

Role: primary

cdpoptitri@gmail.com

+227679161300

Other Identifiers

22SANIC204

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ANRS-0467

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRD_2024_CEPED_OptiTri_GC

Identifier Type: -

Identifier Source: org_study_id